Internal Review Board Resources

Embark Program IRB Application Process

  1. Project proposal is approved through the Embark Program.
  2. Institutional Review Board (IRB) application (or amendment) is prepared by the student and mentor collaboratively.
  3. All IRB applications require a pre-review by one of the Medical Education Directors:
  4. IRB application (or amendment) is submitted to appropriate IRB.

Who should be the principal investigator (PI) on the capstone project IRB? For IRB/regulatory purposes, the mentor should be listed as the PI on all IRB applications. This does not detract from the student’s leading role in the project as a co-investigator.

CITI Training
CITI Training – Required for all key personnel on an IRB application

CITI Training Instructions

Please be aware you may be required to complete additional modules based on your research study role and the specifics of the study. You only need to complete the modules for the institution to which you intend to submit your IRB application.
Beaumont IRB

Please submit to the Beaumont IRB for all Beaumont-based human subjects research projects. If you think your project does not involve human subjects but is still occurring at Beaumont or with Beaumont resources, you may still need to submit an IRB application for official Beaumont IRB excusal. Please contact the Medical Education Directors for assistance with this process.

For IRB applications to Beaumont, please use the following information and steps.

To access the Beaumont IRB online submission system (iMedRIS) Beaumont IRB

  • Students – for iMedRIS registration, please see details on your Moodle page.
  • Before you will be able to register for iMedRIS, your CITI training (affiliate with William Beaumont Hospital) needs to be completed.
  • You will need your Beaumont ID to log on to iMedRIS. This is the same login you use for HealthStream.
  • For help with Beaumont ID, please contact: Dawn Burgess at dawn.burgess@beaumont.org
  • Beaumont IRB (HIC) iMedRIS Password Help – If you are already registered, and need help with your password, please click on the link and go to password self-service. If this doesn't work, please call the Beaumont IT help desk at (888) 481-2448. You will need to update your password once a year.
  • Please view the following instruction documents prior to completing your IRB application. Students and mentors should work together to complete the IRB documents. For IRB/regulatory purposes, the mentor should be listed as the principal investigator (PI) on all IRB applications. This does not detract from the student’s leading role in the project as a co-investigator. Note, only Beaumont employees can serve as PI; fellows, residents, and OUWB faculty members cannot serve in this capacity. 

  • OUWB Sample IRB Application for Beaumont 
  • OUWB Checklist for new IRB application at Beaumont
    • Please click on the "Help" button in the upper-right corner of the iMedRIS home page for more help documents.
    • Complete the Beaumont Computer-based Training (required to submit to Beaumont IRB) Please refer to Moodle page for more information.

  • To log in directly to HealthStream, access the URL:  http://www.healthstream.com/hlc/beaumonthealth
  • After logging on to your account, please search the catalog and add the following module:
    • Research Institute Compliance Plan - RES100
    • Once you complete the module, please use the completion report function and save a copy of your transcript. Be sure that the four modules listed below are visible in your transcript
      • Research Institute Compliance Plan - RES100
      • General Compliance - COMP101
      • EPIC Confidentiality and Computer Systems Usage Agreement - BHMND133
        • Annual Privacy Education - BHMND101 - For new projects, this document should be uploaded to "other study documents." For amendments, this document should be uploaded to Embark project table, typically section 5.2, along with your proposal and the assurance form from Tracy Wunderlich-Barillas.
  • All key personnel need to complete the online Beaumont Conflict of Interest (COI) form. The COI Smart process will be initiated once you register for iMedRIS. You will receive an email from Beaumont containing additional information. 

  • If your project will require funding through the Embark Program, please complete and submit a funding request in the Embark Portal-Oakland.caseware.com prior to submitting your IRB. Funds will not be distributed until IRB approval is granted.

  • Once the IRB documents (including CITI training, COI, Compliance Training, and all application documents) are completed, please follow the instructions on Moodle for conducting and IRB pre-review.
Oakland IRB

Please submit to the Oakland University IRB for all Oakland University, and/or community-based human subjects research projects. If you think your project does not involve human subjects but is still occurring at Oakland University, or is supported with Oakland University resources, you may still need to submit your study information through the Oakland University IRB for official "Non-human Subjects Research Determination" 

For IRB applications to Oakland University, please use the following information and steps.

  • Anyone submitting applications to the IRB for human subjects research should now use the Cayuse application.

    More information can be found here

  • Please view the instruction documents referred to in the above links prior to beginning your Cayuse submission and to download all forms, templates, and tables that are applicable to your research project. Students and mentors should work together to complete the IRB documents. For IRB/regulatory purposes, the mentor should be listed as the principal investigator (PI) on all IRB applications. This does not detract from the student’s leading role in the project as a co-investigator.

  • Once all IRB documents (including variables or data collection tools, recruitment materials including fliers and email/verbal scripts, and informed consent documents) are completed, please upload to Opencaseware, select the appropriate medical education director, and make sure your mentor signs off.
Statistical Consultation
  • Please submit an appointment request with Ms. Michelle Jankowski or Mr. Patrick Karabon using this form: OUWB Statistical Consultation Request Form.
  • Please use these guidelines to prepare your data for analysis. Review these guidelines and apply the advice when cleaning up your data before you meet with Ms. Jankowski. This will assist you in having a more productive meeting the first time, and hopefully, it will prevent back-and-forth delays due to data not being ready for analysis.
  • Please be aware that statistical consultation is needed by students across all years (M1-M4) who are at various points in their research projects. There may be a backlog of consultation requests depending on the time of year. Every effort is made to accommodate all requests. 
Statistical Analysis Software
Students are eligible to download the Oakland University site license of SPSS. 
  • Go to MySail on Oakland's website and log in.
  • In the right column is a link to the OU Appstore. 
  • Install the Apporto agent that allows download of the software. 
  • Access to two versions of SPSS is available.
Data Collection

Once your IRB application is approved, you may proceed with data collection specifically as described in your approved protocol(s).

  • M1 and M2 students will not have remote access to EPIC. M1 and M2 students will only be able to obtain access to EPIC while on a Beaumont campus and Beaumont computer. 
Data Storage

Once your IRB application is approved, please use the approved mechanisms for data storage, as outlined in your approved IRB protocol(s).